Identification. An OTC denture repair kit is a device consisting of a material, such as a resin monomer system of powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks. The device may be available for purchase over-the counter.
Classification. Class II. The OTC denture repair kit is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 872.9. The special controls for this device are FDA's:
“Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and
“OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits.”
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